Trial record 1 of 1 for:
P3T11
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00258895 |
Recruitment Status :
Completed
First Posted : November 28, 2005
Results First Posted : September 28, 2009
Last Update Posted : April 14, 2016
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Diphtheria Tetanus Pertussis |
Intervention |
Biological: DAPTACEL®: DTaP |
Enrollment | 649 |
Participant Flow
Recruitment Details | Participants were enrolled from 30 March 2005 to 02 March 2006 at 22 US sites. |
Pre-assignment Details | A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | DAPTACEL®-Primed | Pentacel®-Primed |
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Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. | Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study. |
Period Title: Overall Study | ||
Started | 487 | 162 |
Completed | 477 | 159 |
Not Completed | 10 | 3 |
Reason Not Completed | ||
Lost to Follow-up | 3 | 1 |
Protocol Violation | 6 | 2 |
Withdrawal by Subject | 1 | 0 |
Baseline Characteristics
Arm/Group Title | DAPTACEL®-Primed | Pentacel®-Primed | Total | |
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Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. | Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study. | Total of all reporting groups | |
Overall Number of Baseline Participants | 487 | 162 | 649 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 487 participants | 162 participants | 649 participants | |
<=18 years |
487 100.0%
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162 100.0%
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649 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 487 participants | 162 participants | 649 participants | |
4.1 (0.14) | 4.1 (0.16) | 4.1 (0.14) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 487 participants | 162 participants | 649 participants | |
Female |
244 50.1%
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83 51.2%
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327 50.4%
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Male |
243 49.9%
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79 48.8%
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322 49.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 487 participants | 162 participants | 649 participants |
487 | 162 | 649 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: | Medical Director |
Organization: | Sanofi Pasteur Inc. |
EMail: | RegistryContactUs@sanofipasteur.com |
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT00258895 |
Other Study ID Numbers: |
P3T11 |
First Submitted: | November 24, 2005 |
First Posted: | November 28, 2005 |
Results First Submitted: | August 18, 2009 |
Results First Posted: | September 28, 2009 |
Last Update Posted: | April 14, 2016 |